Follicum AB (“Follicum” or the “company”) today announced that the clinical Phase IIa study with a cream-like formulation of FOL-005 will re-start, following a pause due to the Covid-19 pandemic. To increase the recruitment rate, a third study centre has been contracted. The study comprises approximately 200 male patients with hair loss who are treated daily for four months with the newly developed formulation of FOL-005 or placebo. The study is being conducted at the Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin, proDERM in Hamburg, and the new center, CentroDerm® in Wuppertal.
In two previous clinical studies, FOL-005 administered as an intradermal injection has been shown to be an effective and safe treatment for stimulation of hair growth. The current Phase II study aims to investigate the safety, efficacy and response of the drug candidate FOL-005 in a topical formulation. The patients themselves will apply a cream with three different strengths of FOL-005 or placebo in the scalp, once daily in the evening. The study is expected to be completed and the results communicated in spring 2021.
CEO Jan Alenfall comments:
“It is very gratifying that we now can re-start the study and continue the recruitment of patients. As we re-start, we have contracted another experienced and reputable study centre to increase the recruitment rate. The aim of the current study is to confirm the interesting results that we have seen in previous studies, this time in a larger patient group and with the cream-like formulation that we developed and tested during the past year. Hair loss affects a very large number of people, both women and men. Nonetheless, there are few effective and safe treatments available. We hope that FOL-005 will prove to be a breakthrough.”
FOL-005 is a modified, short version of the endogenous protein, osteopontin. In two completed clinical studies, treatment with FOL-005 has been shown to be effective and safe. The first study was done in healthy volunteers while the other one was conducted in alopecia patients, i.e. in men with incipient baldness. In both studies, patients were treated at the clinic with intradermal injections, 2 or 3 times a week.
Unwanted hair loss (alopecia), which is commonly referred to as “baldness”, affects about a third of all men between the ages of 20 and 50 in the Western world. For men over 50 years of age, the proportion with hair loss is even higher, about 50%. A significant proportion of women also suffer from unwanted hair loss. All in all, this translates to a huge market for an effective and safe hair-stimulating drug. Today, there are principally only two medicinal substances used for treatment. Sales of these drugs amount to more than USD 3 billion annually. Compared to existing preparations, FOL-005 is likely to offer several benefits, such as fewer side effects, easier dosage and higher proportion of responders.
For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Telephone: +46 (0)709 31 51 15
This information is information that Follicum is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the contact persons above, for publication on the 3rd of June, 2020.
About the Clinical Research Center for Hair and Skin Science (CRC), Berlin, Germany
The Clinical Research Center for Hair and Skin Science (“CRC”) is part of the skin clinic at the Charité – University Hospital in Berlin. CRC conducts experimental research and offers specialist expertise in the area of skin and hair research. CRC has conducted several clinical studies in various hair indications and has solid qualifications with specialization in Phase I and II clinical studies.
proDERM is a full-service contract research organization in Hamburg, Germany, specializing in conducting clinical studies in the areas of skin, mucosa, hair, eyes and mouth. proDERM carry out studies on medicinal products, medical devices, cosmetics, nutritional supplements and consumer goods alike, and competently comply with the various regulatory and legal requirements. proDERM is a competent, full-service partner, supervising clinical projects in all phases.
Since Centroderm® was founded in 2000, more than 150 clinical studies (GCP / ICH studies) in Phase II-IV as well as studies under the Medical Devices Act (MPG) within dermatology, oncology, allergy and aesthetic medicine have been conducted by the CentroDerm GmbH team. They have vast experience from hair studies.
About Follicum AB
Follicum is a biotech company focused on the discovery and development of peptide-based drugs. The primary focus is in hair growth stimulation, where Follicum has obtained very promising results with FOL-005 in several clinical trials. In diabetes, Follicums research has resulted in a new peptide class which significantly increases the release of insulin in pre-clinical models. The company was founded in 2011, and is based in Lund, Sweden. Follicum is listed on the Swedish small cap exchange Spotlight since 2014. www.follicum.com.